Structured Nursing Education for Hemodialysis Patients

July 26, 2026 updated by: Yasemin OZYER, Sinop University

The Effect of a Structured Nursing Education Program on Attitudes Toward Diet Therapy, Self-Care, and Chronic Disease Self-Management in Patients Undergoing Hemodialysis: A Randomized Controlled Trial

This randomized controlled trial was designed to evaluate the effects of a structured nurse-led education program on attitudes toward diet therapy, self-care activities, and chronic disease self-management among patients undergoing maintenance hemodialysis. Sixty eligible patients receiving maintenance hemodialysis were randomly assigned to either the intervention group (n = 30) or the control group (n = 30). Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face educational sessions delivered over four weeks (two sessions per week), while the control group received routine care without additional educational intervention. The primary outcomes were attitudes toward diet therapy, self-care activities, and chronic disease self-management, which were assessed before and after the intervention using the Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), the Self-Care Activities Screening Scale-14 (SCAS-14), and the Chronic Illness Self-Management Scale (CISMS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial was designed to evaluate the effects of a structured nurse-led education program on attitudes toward diet therapy, self-care activities, and chronic disease self-management among patients undergoing maintenance hemodialysis.

The study was carried out in the hemodialysis unit of a private dialysis center in the Black Sea region of Türkiye. Sixty eligible patients receiving maintenance hemodialysis were randomly assigned to either an intervention group (n = 30) or a control group (n = 30). Cluster randomization at the dialysis-session level was used to minimize contamination between participants. Outcome data were analyzed by a blinded statistician.

Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face sessions delivered over four weeks (two sessions per week). The educational program included chronic kidney disease and hemodialysis, treatment adherence, dietary therapy, nutritional management, fluid and electrolyte restrictions, self-care skills, chronic disease self-management, anemia management, and reinforcement of learning. The control group received routine care without additional educational intervention.

The primary outcomes were attitudes toward diet therapy, self-care activities, and chronic disease self-management. These outcomes were assessed at baseline and immediately after completion of the intervention using validated instruments, including the Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), the Self-Care Activities Screening Scale-14 (SCAS-14), and the Chronic Disease Self-Management Scale (CDSMS).

The educational program was developed based on Orem's Self-Care Deficit Nursing Theory and was designed to address self-care, dietary therapy, and chronic disease self-management among patients undergoing maintenance hemodialysis.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Sinop
      • Sinop, Sinop, Turkey (Türkiye), 57000
        • Private Sinop Dialysis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Receiving maintenance hemodialysis treatment.
  • Able to communicate in Turkish.
  • Able to read and write.
  • Willing to participate and provided written informed consent.

Exclusion Criteria:

  • Cognitive impairment or severe psychiatric disorder preventing participation.
  • Serious medical condition preventing completion of the education program.
  • Participation in another structured educational intervention during the study period.
  • Withdrawal of consent before completion of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants in the intervention group received a structured nurse-led education program consisting of eight face-to-face sessions delivered over four weeks (two sessions per week), in addition to routine hemodialysis care. The program covered chronic kidney disease, hemodialysis, dietary therapy, nutrition, fluid management, self-care, chronic disease self-management, anemia management, and reinforcement of learning
Behavioral: Structured Nursing Education Program
Participants received a structured nurse-led education program consisting of eight face-to-face sessions delivered over four weeks (two sessions per week). The program included education on chronic kidney disease, hemodialysis, dietary therapy, nutrition, fluid management, self-care, chronic disease self-management, anemia management, and reinforcement of learning
No Intervention: Control Group
Participants in the control group received routine hemodialysis care provided by the dialysis center and did not receive the structured nurse-led education program during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Information Form
Time Frame: Baseline and immediately after completion of the 4-week intervention
The Participant Information Form was developed by the researchers to collect participants' sociodemographic and clinical characteristics. The questionnaire included items on age, sex, educational level, marital status, smoking status, alcohol consumption, and duration of hemodialysis treatment.
Baseline and immediately after completion of the 4-week intervention
Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS)
Time Frame: Baseline and immediately after completion of the 4-week intervention
The Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS), originally developed by Onbe and Kanda (2018), was used to evaluate patients' attitudes toward dietary therapy. Hemodialysis Patients' Attitudes Toward Diet Therapy Scale (HPADTS). The scale consists of 16 items scored on a 4-point Likert scale, with total scores ranging from 16 to 64. Higher scores indicate more positive attitudes toward diet therapy. The scale consists of 16 items distributed across three subscales: Behavioral Tendency Influenced by Cognition (BTIC) (7 items), Behavioral Tendency Influenced by Food Culture (BTIFC) (6 items), and Negative Effects Leading to Dietary Modification (NELDM) (3 items). Each item is rated on a four-point Likert scale. The final three items are reverse scored. Higher total scores indicate more positive attitudes toward dietary therapy.
Baseline and immediately after completion of the 4-week intervention
Self-Care Activities Screening Scale (SASS-14)
Time Frame: Baseline and immediately after completion of the 4-week intervention
Self-care activities were assessed using the Self-Care Activities Screening Scale (SASS-14), which comprises 14 items grouped into four subscales: Health Consciousness (HC), Nutrition and Physical Activity (NPA), Sleep (SLP), and Interpersonal and Intrapersonal Coping Skills (IICS). Items are rated on a six-point Likert scale, yielding total scores ranging from 14 to 84, with higher scores indicating greater engagement in self-care activities. In the original validation study, the overall Cronbach's alpha coefficient was 0.80 (Bermejo-Martins et al., 2021). The Turkish adaptation demonstrated good internal consistency, with a Cronbach's alpha coefficient of 0.85 (Tarus et al., 2024).
Baseline and immediately after completion of the 4-week intervention
Chronic Disease Self-Management Scale (CDSMS)
Time Frame: Baseline and immediately after completion of the 4-week intervention
Chronic disease self-management was assessed using the Chronic Disease Self-Management Scale (CDSMS). The instrument consists of 21 items across four subscales: Self-Stigma (7 items), Coping with Stigma (5 items), Health Care Efficacy (4 items), and Treatment Adherence (5 items). All items are scored using a five-point Likert scale. The reported Cronbach's alpha coefficients for the subscales range from 0.715 to 0.879. The Turkish validity and reliability study of the instrument was conducted by Öztürk et al. (2021). Chronic Disease Self-Management Scale (CDSMS). The scale consists of 21 items scored on a 5-point Likert scale, with total scores ranging from 21 to 105. Higher scores indicate better chronic disease self-management.
Baseline and immediately after completion of the 4-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinop University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2025

Primary Completion (Actual)

October 10, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

July 19, 2026

First Submitted That Met QC Criteria

July 26, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 26, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 0 2 5 / 2 5 7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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